Flip open catheter package
A catheter package includes an elongated case. A cap is attached to the case by a flexible strap. The case receives the tubing portion of a catheter. The catheter has a funnel attached to the tubing. The funnel has a seal portion releasably engageable with the case. The cap is releasably engageable with the funnel to retain the funnel in contact with the case. A user can flip the cap off the funnel to permit removal of the catheter from the case. The funnel may include ridges or a tactile ring to improve the user's grip on the funnel. An adaptor may be disposed between the funnel and case to allow mating of different cross sectional shapes of the funnel and case. A hydration device may be inserted in the case. Alternately, a tubular liner may be inserted in the case to separate liquid water on the outside of the liner from the catheter tubing on the inside of the liner. A window in the liner mounts a patch of filter material that permits the passage of water vapor into the interior of the liner.
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This application is a Divisional of U.S. application Ser. No. 15/314,436, filed Nov. 28, 2016 which is a U.S. National Stage of PCT of International Patent Application No. PCT/US2015/033344, filed May 29, 2015 which claims the benefit of and priority to U.S. Provisional Patent Application Ser. No. 62/005,635, filed May 30, 2014, the contents of which are incorporated by reference herein.
FIELD OF THE DISCLOSUREThis disclosure relates generally to packaging for medical devices such as urinary catheters. More particularly, this disclosure relates to compact catheters, such as urinary catheters, and the packaging, storing and hydrating/lubricating of such catheters.
BACKGROUNDIntermittent catheterization is a good option for many users who suffer from various abnormalities of the urinary system. A common situation is where single use, individually packaged, sterile catheters are used. Catheters often include a surface treatment that reduces friction to allow for easier and less traumatic insertion into and through the user's urethra.
One such surface treatment includes providing a hydrophilic coating on the exterior surface of the catheter. In a hydrophilic coated catheter, the catheter is provided with a thin coating disposed on the outer surface of the catheter. When this coating is activated by contact with a hydrating medium, such as liquid water or water vapor, it becomes lubricious and provides an extremely low coefficient of friction surface.
The hydrating medium may be added to the catheter package after opening. Another embodiment provides liquid water in a separate compartment that is opened to allow the water to enter the catheter containing compartment for direct contact with the hydrophilic coating. Or the hydrating medium could be a wick, sachet or liquid sequestering element wetted with a liquid, such as water. Water vapor from the wick hydrates the catheter. Catheter packages employing a wick are described in greater detail in U.S. Pat. Nos. 8,205,745 and 8,356,457 to Murray et al. and in U.S. Patent Application Publication Nos. 2009/0131917 to Kavanagh et al. and 2012/0228165 to Murray et al., all of which are incorporated herein by reference.
Another type of surface treatment is a gel-coated catheter in which a gel-lubricant is applied to the surface of the catheter. The gel-lubricant may be applied to the catheter surface just before or during the packaging operation or as the catheter is being inserted by the user.
Regardless of whether a surface treatment is used or what type of surface treatment is used, some type of package for the catheter is required. In the past various kinds of packages have been used, including molded containers of assorted sizes and shapes, bags and pouches made of plastic or metal foil, and similar kinds of devices. An example of a tubular type of package is shown in U.S. Published Application No. 2005/0043715. While these prior art packages generally accomplish the objective of protecting the catheter during transport, storage and preparation for use, they suffer from disadvantages that range from fundamental—the packages break open prematurely; to economic—the package designs are wasteful of material and labor; to the annoying—the packages confuse users as to how to open them, or the packages tend to spill the hydrating medium upon opening. What is needed is a catheter package that is economical to manufacture and fill, reliable throughout its useful life, and simple and intuitive to use. It is also desirable to have a compact package whose transport and use can be discreet.
SUMMARYIn one aspect, the catheter package of the present disclosure includes an elongated case having a closed end and a rim at the opposite end. The rim defines an open end of the case. The package further includes a cap which is tethered to the case by a flexible strap. The case is sized to receive and enclose the tubing portion of a catheter. The funnel of the catheter is releasably engageable with the package case at or near the rim, with all or most of the funnel remaining on the exterior of the case. The engagement of the funnel with the case near the rim seals any hydrating medium in the case. The cap is releasably engageable with the funnel. The strap length is such that when the cap is engaged with the funnel the strap and cap will retain the funnel in contact with the case at the open end. Preferably the cap snaps into and closes the open end of the funnel to prevent entry of contaminants into the funnel and to prevent any hydrating medium from exiting the package through the tubing and funnel. A user can flip the cap off the funnel and flex the strap slightly away from the axis of the case to permit removal of the catheter from the case. After use the catheter can be replaced in the case and the cap can be reclosed if a user so chooses. The strap may be integrally molded
In another aspect, the present disclosure concerns a package of the type described having a grommet in the interior of the case. The grommet is filled with a lubricating gel. Upon removal of the catheter from the package the catheter tubing is drawn through the lubricating gel in the grommet, thereby coating the catheter tubing with gel and making it ready for use.
In still another aspect, the present disclosure is directed to a catheter specially adapted for use with the package of the type described. Since the package does not have a hygienic sleeve for the catheter, the user is dependent on the funnel for catheterization as they cannot touch the catheter tube (due to possible contamination issues). To improve the user's grip on the funnel during general use of the catheter it is beneficial to provide ridges on the funnel. Alternately, the funnel's overall shape could also improve grip. From a touch perspective a tactile zone on the funnel ends allows the user to feel when they are near an end of the funnel. This decreases the probability of the user's fingers accidentally slipping from the funnel and contacting the catheter tubing or urine.
The package of the present disclosure can also be adapted for use with a male catheter. Male catheters are difficult to fit inside a compact package. The male catheter of the present disclosure addresses this by being folded inside the case of the package. The outer grip portion of the catheter may be made slideable along the catheter to be used as a gripper and enhance hygienic benefits.
In packages having a hydrating sachet it may be advantageous to add an adaptor to the top of the package case. The adaptor is press fit into the opening at the top of the case. The adaptor has an external cross section that matches the internal cross section of the package case. It also has an internal passageway whose cross section matches that of a seal section on either the bottom of the funnel or the end of the catheter.
An alternate form of hydration can be the straightforward addition of liquid water to the package case prior to installation of the catheter. Following introduction of about 1.5 ml of water to the case, a molded liner is inserted into the case. The liner has a flange on one end that is press fit into the opening at the top of the case to form a seal between the liner and the case. Then the catheter is inserted into the liner. The bottom of the funnel has a portion which may fit inside the liner in a press fit seal. Then the strap of the case is folded up and the cap on the end of the strap is folded down onto the top end of the funnel. Finally, a tamper-evident label may be placed on the closed cap to complete the package. A further alternate form uses the liner as just described but replaces the strap-retained cap with a fully removable hollow cap that encloses the catheter funnel and is removably connectable to the case. A further alternate form of hydration could be the addition of liquid water in the package case but without the liner just described. In this embodiment the liquid water would be in the package case alongside the catheter.
In another aspect a flexible label could be substituted for the molded strap. The label may be adhesively secured to the case and extend to a point of attachment with the cap. Attachment of the label to the cap may be either adhesive or mechanical or both.
The present disclosure is directed to a catheter package for an intermittent catheter. The catheter itself is shown at 10 in
The funnel 14 has an upper body portion 16 and a lower seal portion shown generally at 18. The upper or free end 17 (
Further details of the seal 18 at the lower end of the funnel include a beveled lower portion 22 joining a cylindrical transition section 24 which is adjacent to a bead 26. The bead 26 may have a somewhat larger outside diameter than the transition section 24 for reasons that will become evident below. The beveled lower portion 22 assists in guiding the seal portion 18 into the package as explained below. Other embodiments for the seal portion are possible as each of the components described above may not be necessary in all instances.
At least one radial eyelet 28 is formed in the tubing 12 at the end of the tubing farthest from the funnel 14. The eyelet provides fluid access to the central lumen 12A of the tubing 12. Adjacent the eyelet 28 is a rounded tip 30 that provides a smooth surface to facilitate insertion of the tubing into a urethra. In some embodiments it may be desirable to include more than one eyelet.
Turning now to the catheter package, it is shown generally at 32 in
In one embodiment, the package further may include a strap 50. The strap 50 is an elongated, flexible member which is fixedly attached to the tubular wall 36, preferably at the annular band 40 and tapered section 42 of the tubular wall 36 as best seen in
The boss 54 is spaced laterally from the strap 50 so that there is a space 60 for the free end 17 of the funnel to fit between the boss 54 and the strap 50, as best seen in
Cooperation between the catheter 10 and package 32 is illustrated in
Once the catheter tubing 12 is inside the case 34 and the funnel seal portion 18 is snug against the seal face 48, the strap 50 may, if need be, be flexed somewhat to return the strap to a position where it is adjacent the funnel body 16 and generally parallel to the case axis A. Then the cap 52 is rotated essentially 180° about the hinge 53 as shown by the phantom line positions of the cap in
When the time comes for the catheter to be put to use, a user can simply flip open the cap 52, removing the boss 54 and cap 52 from engagement with the funnel 14. The strap 50 can be pressed aside slightly to permit the user to grasp the funnel and pull the catheter out of the package. If a surface coating was applied to the catheter tubing and a hydrating medium was placed in the package, then the catheter is immediately ready to use. If not, a hydrating medium could be added to the package to lubricate the catheter. Or a gel-coating could be applied to the tubing 12.
It will be noted that the flip open cap 52 is intuitive and familiar to open as it has a similar feature to standard package openings, e.g. a plastic ketchup bottle lid. The product signifies the correct orientation for opening such that there will not be spillage upon opening the product. There can be a tamper-evident label joining the cap to the funnel. The package 32 can be molded as one piece and the catheter can also be a molded component thereby minimizing the cost. The product size can be minimized by keeping to a minimum diameter required for connection to a drainage bag. Another advantage is the package is reclosable and allows for carrying the product after use for later disposal without any leakage or odors.
As can be seen in
It is pointed out that while the cap is shown as a part that snaps into the free end of the funnel, it could be otherwise.
It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the invention disclosed herein. For example, while the funnel is shown engaging the internal surface of the case, the arrangement could be reversed. That is, the funnel could have an external flange or the like that engages the external surface of the case, leaving the internal surface of the case spaced from an interior portion of the funnel.
Also, while it is considered advantageous to manufacture the case, strap and cap as one integral part, alternatively these components could be formed initially as one or more separate parts which are subsequently fastened together. Thus, the strap could be manufactured as a part separate from the case and then subsequently fastened to the case using a suitable connection method. Similarly, the cap could initially be formed separate from the strap and then connected to the strap. In a similar vein, the case could be made of separate parts, such as a separate bottom wall that is fixed to the tubular wall.
While the strap has been shown having initial (that is, prior to closure on a funnel) orientations that are either axial or radial to the case axis, it will be understood that other initial orientations are possible so long as the strap can be moved to a point where the cap can releasably engage the exposed portion of the catheter. Also, the initial angle of the cap relative to the strap could also be other than as shown. Thus, the cap could have an initial position similar to one of the phantom showings of
Further alternate structures could include a cap having a gripping member that is adhesively attached to the outer wall of the funnel. That is, the end of the strap could carry an adhesive gripping member arranged to releasably engage the side and/or the top of the funnel. In another arrangement both the strap and cap could comprise an integral adhesive gripping member. In this case the strap and cap would be a piece of flexible tape adhered at one portion of the tape to the exterior surface of the case's tubular wall and at another portion of the tape to the funnel. The tape would have a length enabling it to extend from the tubular wall to the funnel. It would be advantageous to have the tape extend over the free end of the funnel to close off and seal the funnel opening. Or the tape could extend from one side of the tubular wall, up and over the free end or top of the funnel and then back down to the other side of the tubular wall. The user would remove the tape from the funnel to enable pulling the catheter out of the package for use.
An alternate method of catheter hydration is shown in the catheter package assembly shown in
The funnel 114 has an upper body portion 116 and a lower seal portion shown generally at 118. The upper or free end 117 of the body portion 116 defines a funnel opening 120. While the body portion 116 is shown having a gently curved outer surface that is somewhat parabolic in nature, it will be understood that other exterior shapes for the funnel are possible, such as a frusto-conical shape, perhaps with a suitable lip on the free end. Whatever the exterior shape, the funnel 114 generally has an outer diameter greater than that of the tubing 112. This size, plus the fact that the funnel is not lubricated, makes the funnel 114 a convenient location for grasping the catheter 110 to manipulate it. The funnel may be suitable for connection to a drainage bag, other tubing or any other appropriate apparatus. For example, in one embodiment the opening 120 defined in the free end 117 of the funnel may be large enough or otherwise adapted to receive a urine bag connector.
Near the end of the catheter tubing 112 opposite the funnel 114 is at least one radial eyelet (not shown). The eyelet provides fluid access to the central lumen 112A of the tubing 112. Adjacent the eyelet is a rounded tip 130 that provides a smooth surface to facilitate insertion of the tubing into a urethra. In some embodiments it may be desirable to include more than one eyelet.
Turning now to the catheter package assembly, it is shown generally at 64 in
The package 64 further includes a strap 72. The strap 72 is an elongated, flexible member which is fixedly attached to the tubular wall 67, preferably at or near the rim 66, by a living hinge 74. The other end of the strap 72 mounts a cap 76. The cap is joined to the strap by a living hinge 78. It will be understood that while a living hinge is a convenient method of connecting the cap and strap, other types of hinges are possible. The underside of the cap carries a boss 80. The length of the strap and the size of the cap and boss are such that the cap 76 will engage the opening 120 of a funnel 114 installed in the case 66. Thus, the cap does not engage the case 66, rather it is releasably engageable with the body portion 116 of the funnel 114.
When the cap is closed on the funnel, the boss 60 leads into the opening 120 in the free end of the funnel 114, producing contact between the boss and the internal wall of the funnel. This creates an interference fit and a seal between the boss and the internal surface of the funnel.
In the embodiment of
Cooperation between the catheter 110 and package 64 is illustrated in
Once the catheter tubing 112 is inside the case 66 and the funnel seal portion 118 is snug against the seal face 71, the strap 72 may be rotated 90° about the hinge 74 to place the strap in a position where it is adjacent the funnel body 116 and generally parallel to the case axis A. Then the cap 76 is rotated 90° about the hinge 78. This will allow the boss 80 to fit in the funnel opening 120. The cap 76 and strap 72, together with the interference fit between the seal 118 and case 66, retain the catheter 110 in the package 64.
When the catheter is to be used, a user flips the cap 76 off of the funnel and grasps the outer surface of the funnel with one hand and the case 66 with the other hand. A gentle tilting, twisting or pulling of the funnel relative to the case will dislodge the funnel from the case and allow the user to withdraw the catheter from the case. In the withdrawal process the majority of the tubing 112 passes through the gel grommet 92. As it does so the tubing will become coated with the lubricant. Once the catheter is entirely removed from the case it will be almost completely coated with lubricating gel and thus ready for use.
The gel lubrication of the device will significantly reduce the overall cost of the product. Also, the package is reclosable and allows for carrying the catheter after use for later disposal without any leakage or odor.
Several alternate embodiments of the catheter funnel are shown in
The funnel 114 has an upper body portion 116 and a lower seal portion shown generally at 118. The upper or free end 117 of the body portion 116 defines a funnel opening 120. As in the previous embodiment, the funnel 114 generally has an outer dimension greater than that of the tubing 112. Further details of the seal 118 at the lower end of the funnel include a beveled lower portion 122 joining a cylindrical section 124 on which is mounted an O-ring 126. The O-ring 126 engages the interior of the package case in an interference fit that seals the funnel to the case. The beveled lower portion 122 assists in guiding the seal portion 118 into the case. Other embodiments for the seal portion are possible as each of the components described above may not be necessary in all instances.
The upper body portion 116 in
Looking at
While the preferred arrangement of at least four substantially flat sides is shown, it will be understood that other arrangements are possible for the tactile rings, with the number of flat sides varying from one to several. For example, two spaced, parallel, at least substantially flat sides could be joined by arcuate sides.
All of the embodiments of
The first step in the assembly process is installation of the folded sachet 176 into the case 178, as illustrated by arrow B in
The third step in the assembly process is shown in
Once the catheter 110 is in the adaptor/case sub-assembly the package will be in the state shown at the left hand side of
The final assembly steps are shown in
The case 210 further includes a strap 214 which is attached at one end to the case at a hinge 216. A cap 218 is attached to the other end of the strap 214 by a second hinge 220. Hinges 216 and 220 are preferably living hinges although they could be otherwise. The strap 214 includes a longitudinal rib 222 that extends generally perpendicular to the main body of the strap, thereby producing a T-shaped cross section in the strap. The free edge of the rib 222 has a shape that closely conforms to the contour of the funnel's exterior surface. This construction not only strengthens the strap but it also leaves little or no gap between the strap and the funnel. This prevents entanglement of the strap with items that might otherwise be inserted between the strap and the funnel.
The funnel of a catheter is also visible at 224 in
The upper body portion 226 in the illustrated embodiment may be a two-shot molded component. In such embodiment, the first or internal shot is preferably a relatively rigid material such as ABS or a similar alternative. It forms the seal portion 228 and the body of the funnel 234. The second or external shot is preferably a softer material such as TPE and forms the gripping surface 236 of the funnel, including ridges 238. Interlocking grooves and ribs at 240 near the bottom of the second shot help retain the gripping surface in position on the body. The extreme lower edge of the gripping surface overlies a flange 242 at the top of the seal portion 228. The flange adjoins the top land of the case's rim 212 when the catheter is installed in the case, as will be explained below.
Further details of the seal portion 228 include a beveled lower portion 244 joining a cylindrical section 246. There is a groove 248 in the cylindrical section for receiving an O-ring as shown below. The beveled lower portion 244 assists in guiding the seal portion 228 into the case as explained below. A bore through the center of the seal portion receives the top portion of the catheter tubing 250 in a press fit.
Turning now to
Among the advantages of the packaging assembly with a liner is the liner is relatively easy to install in the case. The liner separates liquid water from the catheter tubing while allowing water vapor to maintain the coating on the tubing in a lubricious condition. When the time comes for the catheter to be put to use, a user can simply flip open the cap 218, removing the boss 270 and cap 218 from engagement with the funnel 224. The strap 214 can be pressed aside slightly to permit the user to grasp the funnel and pull the catheter out of the package. Due to the hydration the catheter is ready for immediate use.
A further alternate embodiment form of a hydrating mechanism is to place liquid water in the case 178 alongside the catheter. This would negate the need for hydration via either a sachet or a hydration liner.
It will be noted that the product signifies the correct orientation for opening such that there will not be spillage upon opening the product. There can be a tamper-evident label joining the cap to the funnel. Another advantage is the package is reclosable and allows for carrying the product after use for later disposal without any leakage or odors.
As mentioned above, it is possible to manufacture the strap as a separate member from the case and then attach the strap to the case at a hinge. One embodiment of such a structure is shown in
An additional embodiment of a strap separate from the case is shown in
An alternative arrangement for the strap 314 is to have a hyperbolic funnel, with flared ends as in
Until now the various illustrated embodiments of the strap contemplate the strap being a molded plastic part. The strap could also be an elongated piece of label stock attached to the cap and case in various manners as will now be illustrated.
A liner hydrating mechanism similar to that shown in
It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the invention disclosed herein. For example, while various O-rings are shown and described as separate, elastomeric rings, they could be molded as an integral part of the component. It is also pointed out that features described in connection with certain figures and embodiments are not limited to those specific embodiments. For example, funnel shapes and/or surfaces can be used with any of the embodiments described above. Similarly, hydrating elements, such as the liner described above, may be used with any one of the various package embodiments shown.
Claims
1. A package for a medical device, the medical device having first and second portions, comprising:
- an elongated case defining an axis and having a rim defining an open end, the rim being sized to permit passage of the first portion of the medical device through said open end and into the elongated case which is sized to removably receive therein said first portion of the medical device, the rim being sized to prevent passage of the second portion of the medical device through said open end;
- a strap connected to the elongated case; and
- a cap connected to the strap and releasably engageable with the second portion of a medical device whose first portion has been inserted into the elongated case.
2. The package of claim 1 wherein the elongated case comprises a tubular wall.
3. The package of claim 2 further comprising a bottom wall attached to one end of the tubular wall.
4. The package of claim 2 wherein one end of the tubular wall has a tapered section terminating at the rim.
5. The package of claim 1 further comprising a boss formed on an underside of the cap.
6. The package of claim 5 wherein the boss has a rounded edge.
7. A catheter and package assembly, comprising:
- a catheter having an elongated tubing and a funnel attached to one end of the elongated tubing, the funnel having a seal portion and a body portion terminating at a free end;
- an elongated case defining an axis and having a rim defining an open end, the rim being sized to permit entry of the elongated tubing and the funnel seal portion through said open end and into the elongated case which is sized to removably receive therein the elongated tubing of the catheter, the rim being sized to prevent passage of the funnel body portion through said open end, the elongated case being releasably engageable by the seal portion of the funnel;
- a strap connected to the elongated case; and
- a cap connected to the strap and releasably engageable with the body portion of a funnel whose seal portion has been inserted into the elongated case.
8. The package assembly of claim 7 wherein the elongated case comprises a tubular wall.
9. The package assembly of claim 8 further comprising a bottom wall attached to one end of the tubular wall.
10. The package assembly of claim 8 wherein one end of the tubular wall has a tapered section terminating at the rim.
11. The package assembly of claim 7 further comprising a boss formed on an underside of the cap.
12. The package assembly of claim 11 wherein the boss has a rounded edge.
13. The package assembly of claim 7 wherein the elongated case has a seal face on its interior near the rim and the seal portion of the funnel is releasably engageable with the seal face.
14. The package assembly of claim 7 wherein the funnel body portion has a seal face on its interior near the free end and the cap is releasably engageable with the seal face at the free end of the body portion of the funnel.
15. The package assembly of claim 7 wherein the strap is initially disposed generally parallel to the axis of the elongated case.
16. The package assembly of claim 7 wherein the strap is initially disposed generally perpendicular to the axis of the elongated case.
17. The package assembly of claim 7 wherein the free end of the funnel defines an opening and the cap has a boss formed on an underside thereof, the boss sized to fit into the opening of the funnel.
18. The package assembly of claim 17 wherein the boss is spaced from the strap to permit the funnel to fit between the boss and the strap.
19. The package assembly of claim 7 wherein the seal portion of the funnel includes a compressible bead.
20. A catheter and package assembly, comprising: a cap releasably engageable with the body portion of a funnel whose seal portion has been inserted into the elongated case; and a strap connected to the elongated case, the cap being connected to the strap.
- a catheter having an elongated tubing and a funnel attached to one end of the elongated tubing, the funnel having a seal portion and a body portion terminating at a free end;
- an elongated case defining an axis and having a rim defining an open end, the rim being sized to permit entry of the elongated tubing and the funnel seal portion through said open end and into the elongated case which is sized to removably receive therein the elongated tubing of the catheter, the rim being sized to prevent passage of the funnel body portion through said open end, the elongated case being releasably engageable by the seal portion of the funnel;
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Type: Grant
Filed: Jan 27, 2020
Date of Patent: Dec 27, 2022
Patent Publication Number: 20200155796
Assignee: Hollister Incorporated (Libertyville, IL)
Inventors: David Hannon (Ballina), Martin McMenamin (Lifford), Adam J. Foley (Swords), Padraig M. O'Flynn (Ballina), Stephen Collum (Castlebar), Enda F. Carter (Galway), Paul C. Fletter (Mt. Prospect, IL), Marine V. Richard (Carrieres sur Seine), Daniel E. O'Brien (Calry), Vincent Naughton (Sligo)
Primary Examiner: Chun Hoi Cheung
Application Number: 16/773,649
International Classification: A61M 25/00 (20060101); B65D 47/14 (20060101); B65D 55/16 (20060101); B65D 81/22 (20060101); A61M 27/00 (20060101);